MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 85MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.038.385S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, the patient underwent removal surgery due to pain.There was no broken implant reported.The surgeon then converted patient to a total hip arthroplasty.Removed hardware successfully.Patient consequence unknown.This report is for one (1) tfna fenestrated helical blade 85mm - sterile.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Additional procode: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Part # 04.038.385s, synthes lot # h786647, supplier lot # n/a, release to warehouse date: 11 dec 2018, expiration date: 31 oct 2028, manufacturing location: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Additional procode: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Part # 04.038.385s, synthes lot # h786647, supplier lot # n/a, release to warehouse date: 11 dec 2018, expiration date: 31 oct 2028, manufacturing location: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2022, the patient underwent removal surgery due to pain.There was no broken implant reported.The surgeon then converted patient to a total hip arthroplasty.Removed hardware successfully.Patient consequence unknown.This report is for one (1) tfna fenestrated helical blade 85mm - sterile.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.: h6: a device history record (dhr) review was conducted: part # 04.038.385s synthes lot # (b)(4).Supplier lot # (b)(4).Release to warehouse date: 11 dec 2018.Expiration date: 31 oct 2028.Manufacturing location: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 85MM - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13481249
• Report Number: 2939274-2022-00390
• Device Sequence Number: 5388150
• Product Code: HSB
• UDI-Device Identifier: 10886982099235
• UDI-Public: 10886982099235
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.038.385S
• Device Catalogue Number: 04.038.385S
• Device Lot Number: H786647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10/125 DEG TI CANN TFNA 170 - STERILE.; 5.0 TI LOCKING SCREW 32- FOR IM NAILS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female